BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MORPHEUS CT PICC

    MDR report key: 3082142 · Received April 11, 2013

    Report

    Report Number
    3082142
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    January 29, 2013
    Report Date
    April 11, 2013
    Manufacturer
    ANGIODYNAMICS INC.
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    PICC HAD A CRACK IN IT AT THE HUB FOUND PRIOR TO ROUTINE DRESSING CHANGE. THIS TYPE OF EVENT HAS OCCURRED THREE TIMES WITH THIS MANUFACTURER'S PRODUCT IN DIFFERENT PATIENTS OVER THE SPAN OF ONE MONTH. THERE WAS NO PATIENT HARM.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?INTRAVENOUS ACCESS.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156271 MORPHEUS CT PICC CATHETER, INTRAVASCULAR, LONG-TERM LJS ANGIODYNAMICS INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR NO OTHER THERAPIES